Trial Outcomes & Findings for Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver (NCT NCT03366155)

Last Updated: 2026-08-28

Results Overview

Response rate is defined as the number of participants who experience a partial response (PR) or complete response (CR) using the study treatment was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) and reported with an 80% confidence interval. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 months

Results posted on

2026-08-28

Participant Flow

History and physical, lab evaluation, computed tomography, etc. are performed after the subject has signed the consent for this study for screening. 28 participants were screened for this study and 4 were initial screen failures. Screen failures are defined as participants who consent to participate in the clinical trial but are not subsequently assigned to the study intervention. Thus, 24 participants were enrolled.

Participant milestones

Participant milestones
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)
Overall Study STARTED	24
Overall Study Enrolled	24
Overall Study Intraoperative screen failures	2
Overall Study Completed ≥ 1 cycle of treatment	22
Overall Study Autoimmune disease not comparable with NCT05286814	1
Overall Study Lost to follow-up	1
Overall Study Final cohort of treated participants	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)
Overall Study Participants deemed ineligible after signing consent	1
Overall Study Did not receive treatment.	2
Overall Study Physician Decision	1

Baseline Characteristics

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=24 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)
Age, Categorical <=18 years	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=31 Participants
Age, Categorical >=65 years	4 Participants n=31 Participants
Age, Continuous	51.5 years n=31 Participants
Sex: Female, Male Female	11 Participants n=31 Participants
Sex: Female, Male Male	13 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants
Race (NIH/OMB) Asian	1 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	2 Participants n=31 Participants
Race (NIH/OMB) White	20 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=31 Participants
Region of Enrollment United States	24 participants n=31 Participants
Prior Chemotherapy 5-fluorouracil (5-FU)	20 Participants n=31 Participants
Prior Chemotherapy Oxaliplatin	20 Participants n=31 Participants
Prior Chemotherapy Irinotecan	9 Participants n=31 Participants
Prior Bevacizumab	12 Participants n=31 Participants
Prior Immunotherapy	2 Participants n=31 Participants
Fong Clinical Risk Score	3 score on a scale n=31 Participants
Nagashima Clinical Risk Score	3 Score on a scale n=31 Participants
Positive Regional Lymph Nodes at Hepatic Artery Infusion Pump Surgery	5 Participants n=31 Participants
Pathogenic Mutation in Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS)	13 Participants n=31 Participants
Pathogenic Mutation in B-Raf Proto-Oncogene, Serine/Threonine Kinase (BRAF)	1 Participants n=31 Participants
Microsatellite instability	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 20/24 participants were analyzed because only those participants who have measurable disease present at baseline, have received at least one full cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. The corresponding 80% confidence intervals of the response rates were determined using Clopper-Pearson exact binomial methods.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=20 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is serious.	Grade 4 Grade 4 is life-threatening.	Grade 5 Grade 5 is death related to adverse event.
Response Rate (RR) Reported With an 80% Confidence Interval Partial Response	25 percentage of participants Interval 12.7 to 41.5	—	—	—	—
Response Rate (RR) Reported With an 80% Confidence Interval Complete Response	10 percentage of participants Interval 2.7 to 24.5	—	—	—	—

PRIMARY outcome

Timeframe: 6 months

Population: 220/24 participants were analyzed because only those participants who have measurable disease present at baseline, have received at least one full cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. The corresponding 95% confidence intervals of the response rates were determined using Clopper-Pearson exact binomial methods.

Response rate is defined as the percentage of participants who experience a partial response (PR) or complete response (CR) using the study treatment determined by dividing the number of responders by the total evaluable participants. RR was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and reported with an 95% confidence interval. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=20 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is serious.	Grade 4 Grade 4 is life-threatening.	Grade 5 Grade 5 is death related to adverse event.
Response Rate (RR) Reported With a 95% Confidence Interval Partial Response	25 percentage of participants Interval 8.7 to 49.1	—	—	—	—
Response Rate (RR) Reported With a 95% Confidence Interval Complete Response	10 percentage of participants Interval 1.2 to 31.7	—	—	—	—

PRIMARY outcome

Timeframe: 30 days

Population: Not all Grades are appropriate for all adverse events (AEs). Some AEs are listed with fewer than five options for Grade selection." Severe OR medically significant doesn't automatically necessitate serious criteria reportable in an expedited fashion.

Safety was determined by grade 1, 2, 3, 4, and/or 5 serious and/or non-serious adverse events with type and frequency assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=24 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 n=24 Participants Grade 2 is moderate.	Grade 3 n=24 Participants Grade 3 is serious.	Grade 4 n=24 Participants Grade 4 is life-threatening.	Grade 5 n=24 Participants Grade 5 is death related to adverse event.
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Dry eye: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Duodenal perforation: Serious	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Dyspnea: Non-Serious	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Chylothorax: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Constipation: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency CPK increased: Non-Serious	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Creatinine increased: Non-Serious	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Erectile dysfunction: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Fatigue: Non-Serious	4 adverse events	8 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Abdominal distention: Non-serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Abdominal distension: Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Abdominal pain: Non-Serious	2 adverse events	4 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Acidosis: Non-Serious	1 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Activated Partial Thromboplastin Time Prolonged: Non-Serious	1 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Alanine aminotransferase increased: Non-Serious	1 adverse events	25 adverse events	22 adverse events	6 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Alkaline aminotransferase increased: Non-Serious	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Fever: Non-Serious	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Gastritis: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Generalized edema: Non-Serious	1 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Heart failure: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hematoma: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hemorrhoidal hemorrhage: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hyperhidrosis: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hyperkalemia: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hypokalemia: Non-Serious	0 adverse events	0 adverse events	5 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hypotension: Non-Serious	0 adverse events	4 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hypoxia: Non-Serious	0 adverse events	2 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Infections and infestations - Other, specify (Influenza A): Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Device related infection: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Device related infection: Serious	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Alopecia: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Alkaline phosphatase increased: Non-Serious	2 adverse events	16 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Diarrhea: Non-Serious	1 adverse events	6 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Edema limbs: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Edema trunk: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pleural effusion: Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pleuritic pain: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pneumothorax: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Premature menopause: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pruritis: Non-Serious	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pulmonary edema: Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Rash acneiform: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Rash maculopapular: Non-Serious	2 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Renal and urinary disorders - Other, specify, (Oliguric renal failure): Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Renal and urinary disorders - Other, specify, (Ureter injury)	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Sepsis: Serious	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Sinus tachycardia: Non-Serious	0 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Infusion-related reaction: Non-Serious	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Anemia: Non-Serious	0 adverse events	41 adverse events	28 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Anorexia: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Arthralgia: Non-Serious	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Chest pain: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Ascites: Non-Serious	1 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Aspartate aminotransferase increased	1 adverse events	22 adverse events	22 adverse events	9 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Atelectasis: Non-Serious	1 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Atrial fibrillation: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Back pain: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Belching: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Bloating: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Blood bilirubin increased: Non-Serious	1 adverse events	16 adverse events	4 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Bile duct stenosis: Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Cardiac arrest: Serious	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Fibrinogen decreased: Non-Serious	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Flu-like symptoms: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency injury,poisoning and procedural complications,Other,specify (abdominal fluid collection):Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Skin ulceration: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Stroke: Serious	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Syncope: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Thromboembolic event: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Thromboembolic event: Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Urinary retention: Non-Serious	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Urinary tract infection: Non-Serious	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Vascular disorders - Other, specify (Pseudoaneurysm of the GDA): Serious	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Weight gain: Non-Serious	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency White blood cell decreased: Non-Serious	0 adverse events	7 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Wound dehiscence: Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Wound infection: Non-Serious	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hypertension: Non-Serious	0 adverse events	4 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Hypoalbuminemia: Non-Serious	0 adverse events	16 adverse events	2 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency INR increased: Non-Serious	1 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Insomnia: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Intra-abdominal hemorrhage: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Lymphocyte count decreased: Non-Serious	0 adverse events	9 adverse events	3 adverse events	2 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Mania: Non-Serious	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Mucositis oral: Non-Serious	0 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Muscle weakness lower limb: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Nausea: Non-Serious	2 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Neutrophil count decreased: Non-Serious	0 adverse events	6 adverse events	2 adverse events	1 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Non-cardiac chest pain: Non-Serious	0 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Otitis media: Non-Serious	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pain: Non-Serious	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Papulopustular rash: Non-Serious	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pericardial effusion	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Peripheral sensory neuropathy	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Platelet count decreased: Non-Serious	0 adverse events	6 adverse events	3 adverse events	0 adverse events	0 adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency Pleural effusion: Non-Serious	2 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: Date of Hepatic Artery Infusion Pump (HAIP) insertion through death or study completion, up to 63.1 months

Population: 20/24 participants were analyzed because only those participants who have received at least one full cycle of therapy will be considered evaluable for this outcome.

OS is defined as the median amount of time a participant survives after therapy determined using the Kaplan Meier method. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log (complementary log-log) transformation. As pre-specified in the protocol Statistical Section 10.4.3 Analysis of the Secondary Efficacy Endpoints, Overall survival (OS) will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's rationale for reporting a different time frame is "The RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery, which is a function of operating room (OR) availability, and nothing related to the study.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=20 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is serious.	Grade 4 Grade 4 is life-threatening.	Grade 5 Grade 5 is death related to adverse event.
Overall Survival	17.9 Months Interval 10.2 to 28.0	—	—	—	—

SECONDARY outcome

Timeframe: Date of hepatic artery infusion pump (HAIP) insertion through either the date of first hepatic progression or study completion, up to 63.1 months

Population: 20/24 participants were analyzed because only those participants who have received at least one full cycle of therapy will be considered evaluable for this outcome.

Intrahepatic PFS is defined as the duration of time from date of operation to the date of first observation of progressive disease within the liver or death, whichever comes first. Progression was measured by the Response Evaluation Criteria in Solid Tumors and determined using the Kaplan Meier method. Progression is at least a 20% increase in the sum of the diameters of target lesions. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log (complementary log-log) transformation. As prespecified in the protocol Statistical Section 10.4.3 Intra-hepatic PFS will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's (RP) rationale for reporting a different time frame is "The RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery, which is a function of operating room (OR) availability, and nothing related to the study.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=20 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is serious.	Grade 4 Grade 4 is life-threatening.	Grade 5 Grade 5 is death related to adverse event.
Intra-Hepatic Progression-free Survival (PFS)	10.8 Months Interval 7.1 to 23.1	—	—	—	—

SECONDARY outcome

Timeframe: Date of hepatic artery infusion pump (HAIP) insertion through either the date of first extra-hepatic progression or study completion, up to 63.1 months

Population: 20/24 participants were analyzed because only those participants who have received at least one full cycle of therapy will be considered evaluable for this outcome.

Extra-hepatic PFS is defined as the duration of time from date of operation to the date of first observation of progressive disease outside of the liver or death, whichever comes first. Extra-hepatic PFS was determined using the KaplanMeier method\&reported with a 95% confidence interval. Progression was measured by the Response Evaluation Criteria in Solid Tumors. Progression is at least a 20% increase in the sum of the diameters of target lesions. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log(complementary log-log) transformation. As prespecified in the protocol Statistical Section 10.4.3Extra-hepatic PFS will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's((RP) rationale for reporting a differently is "RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery,which is a function of operating room availability\&nothing related to the study.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=20 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is serious.	Grade 4 Grade 4 is life-threatening.	Grade 5 Grade 5 is death related to adverse event.
Extra-hepatic Progression-free Survival (PFS)	8.1 percentage of participants Interval 5.9 to 13.1	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=24 Participants Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is serious.	Grade 4 Grade 4 is life-threatening.	Grade 5 Grade 5 is death related to adverse event.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	24 Participants	—	—	—	—

Adverse Events

Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo

Serious events: 7 serious events

Other events: 23 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=24 participants at risk Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)
Gastrointestinal disorders Abdominal distension	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Hepatobiliary disorders Bile duct stenosis	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Cardiac arrest	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Infections and infestations Device related infection	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Duodenal perforation	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Infections and infestations Sepsis	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Nervous system disorders Stroke	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Vascular disorders Thromboembolic event	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Vascular disorders Vascular disorders - Other, specify: Pseudoaneurysm of the GDA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Injury, poisoning and procedural complications Wound dehiscence	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.

Other adverse events

Other adverse events
Measure	Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo n=24 participants at risk Participants received floxuridine and dexamethasone (FUDR): 0.12 mg/Ideal Body Weight (IBW) X pump volume (vol) X pump FR (Day(D) 1-D14) Dexamethasone: 1 mg/day X pump vol X pump FR (D1-D14) Oxaliplatin 85 mg/m\^2, intravenous (IV), (D15, D1) Leucovorin 400 mg/m\^2, IV, (D15, D1)
Gastrointestinal disorders Abdominal distension	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Abdominal pain	29.2% 7/24 • Number of events 9 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Metabolism and nutrition disorders Acidosis	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Activated partial thromboplastin time prolonged	12.5% 3/24 • Number of events 4 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Alanine aminotransferase increased	83.3% 20/24 • Number of events 54 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Alkaline phosphatase increased	33.3% 8/24 • Number of events 21 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Alopecia	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Blood and lymphatic system disorders Anemia	83.3% 20/24 • Number of events 69 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Metabolism and nutrition disorders Anorexia	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Ascites	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Aspartate aminotransferase increased	83.3% 20/24 • Number of events 54 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Atrial fibrillation	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Musculoskeletal and connective tissue disorders Back pain	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Belching	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Bloating	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Blood bilirubin increased	58.3% 14/24 • Number of events 21 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations CPK increased	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Chest pain - cardiac	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Chylothorax	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Creatinine increased	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Infections and infestations Device related infection	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Diarrhea	20.8% 5/24 • Number of events 7 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Eye disorders Dry eye	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Edema limbs	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Edema trunk	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Reproductive system and breast disorders Erectile dysfunction	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Fatigue	29.2% 7/24 • Number of events 13 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Fever	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Fibrinogen decreased	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Flu like symptoms	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Gastritis	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Generalized edema	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Heart failure	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Vascular disorders Hematoma	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Hemorrhoidal hemorrhage	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Metabolism and nutrition disorders Hyperkalemia	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Vascular disorders Hypertension	4.2% 1/24 • Number of events 7 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Metabolism and nutrition disorders Hypoalbuminemia	37.5% 9/24 • Number of events 18 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Metabolism and nutrition disorders Hypokalemia	12.5% 3/24 • Number of events 5 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Vascular disorders Hypotension	25.0% 6/24 • Number of events 7 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.3% 2/24 • Number of events 5 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations INR increased	16.7% 4/24 • Number of events 6 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Infections and infestations Infections and infestations - Other, specify: Influenza A	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Injury, poisoning and procedural complications Infusion related reaction	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify: Abdominal fluid collection	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Psychiatric disorders Insomnia	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Intra-abdominal hemorrhage	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Lymphocyte count decreased	25.0% 6/24 • Number of events 14 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Psychiatric disorders Mania	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Mucositis oral	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Gastrointestinal disorders Nausea	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Neutrophil count decreased	16.7% 4/24 • Number of events 9 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Non-cardiac chest pain	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Injury, poisoning and procedural complications Otitis media	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
General disorders Pain	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Papulopustular rash	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Pericardial effusion	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Nervous system disorders Peripheral sensory neuropathy	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Platelet count decreased	25.0% 6/24 • Number of events 9 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 3/24 • Number of events 5 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Pleuritic pain	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Reproductive system and breast disorders Premature menopause	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Pruritus	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Rash acneiform	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Oliguric Renal Failure	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Ureter injury	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Cardiac disorders Sinus tachycardia	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Skin and subcutaneous tissue disorders Skin ulceration	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Nervous system disorders Syncope	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Vascular disorders Thromboembolic event	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Renal and urinary disorders Urinary retention	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Infections and infestations Urinary tract infection	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations Weight gain	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Investigations White blood cell decreased	25.0% 6/24 • Number of events 10 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Injury, poisoning and procedural complications Wound complication	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Injury, poisoning and procedural complications Wound dehiscence	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.
Infections and infestations Wound infection	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.

Additional Information

Dr. Jonathan M. Hernandez

National Cancer Institute

Phone: 240-760-6072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place